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CoVClear Mutation Panel

Research Use Only (RUO)

The MiRXES CoVClear Mutation Panel is a real-time RT-PCR assay for the qualitative detection of key mutations in the receptor-binding domain (RBD) of the spike protein of the SARS-CoV-2 virus (E484K and L452R) from nasal specimens confirmed to be positive for SARS-CoV-2 by RT-PCR.

This tool can be used to identify COVID-19 positive patients who may have been infected by SARS-CoV-2 variants of concern (VOC), such as the Beta (B.1.351 – South Africa) lineage or Delta/Kappa (B.1.167 – India) lineage.

Key

features

Detects key SARS-CoV-2 variants

Individual panels to detect key mutations for identification of key variants of concern and variants of interest identified by the WHO.

Fast
results

Can be used for quick identification of COVID-19 positive patients who may be infected by variants of concern or interest before sequencing.

Reliable
performance

High sensitivity and specificity. Limit of detection at 2-3 copies per microliter. Uses N gene as internal control for COVID-19 diagnosis validation

Lab
ready

Compatible with current industry-standard RT-PCR instruments and data analysis software without any additional installations.

Quality
assured

Manufactured and distributed under ISO13485 quality management system.

SARS-CoV-2 Variants Description

The World Health Organization (WHO) has defined a SARS-CoV-2 isolate as a variant of interest (VOI) if it is phenotypically changed compared to a reference isolate of has a genome with mutations that lead to amino acid changes associated with established or suspected phenotypic implications; AND has been identified to cause community transmission/multiple COVID-19 cases/clusters, or has been detected in multiple countries.

A VOI is further classified as a variant of concern (VOC) if, through a comparative assessment, it has been demonstrated to be associated with:

  • Increase in transmissibility of detrimental change in COVID-19 epidemiology;
  • Increase in virulence or change in clinical disease presentation; or
  • Decrease in effectiveness of public health and social measures or available diagnostics, vaccines, therapeutics.

WHO-designated variants of concern (VOCs) and selected variants of interest (VOIs), as of 31 May 2021.

Lineage
VOC/VOI
First detected in
Mutation Panel Targets
Other characteristic spike mutations
B.1.1.7 (Alpha)
VOC
United Kingdom
69/70del, 144del, N501Y, A570D, D614G, P681H, T716I, S982A, D1118H
B.1.351 (Beta)
VOC
South Africa
E484K
D80A, D215G, 241/243del, K417N, N501Y, D614G, A701V
B.1.1.28.1, alias P.1 (Gamma)
VOC
Brazil
E484K
L18F, T20N, P26S, D138Y, R190S, K417T, N501Y, D614G, H655Y, T1027I, V1176F
B.1.617 (Delta/Kappa)
VOC
India
L452R
D614G, P681R
B.1.525 (Eta)
VOI
Multiple countries
E484K
Q52R, A67V, 69/70del, 144del, D614G, Q677H, F888L
B.1.427/B.1.429 (Epsilon)
VOI
USA, California
L452R
S13I, W152C, D614G

Ordering

information

CoVClear Mutation Panel test kits are sold as individual mutation panels + a common reagent pack.

Product
Pack Size
Contents
Catalogue No.
CoVClear Mutation Panel Reagent Pack
200 tests/kit
Reaction Master Mix, Enzyme Mix, Positive Control (WT+N), Negative Control
FGS0032R
CoVClear Mutation Panel E484K
200 tests/kit
Primer-Probe Mix (E484K+N), Positive Control (E484K+N)
FGS0035R
CoVClear Mutation Panel L452R
200 tests/kit
Primer-Probe Mix (L452R+N), Positive Control (L452+N)
FGS0036R

Contact us

Singapore (Global HQ)
T: +65 6816 2931
E: sales@mirxes.com